1. Field of the Invention
This invention relates generally to a method and devices for the serial collection, storage, and processing of biopsy specimens for microscopic, chemical, or other types of examination. In particular, the invention relates to biopsy sampling or removing tissue from any remote luminal structure within a patient, and storing the tissue within the removal apparatus in the order sampled through analysis or processing.
2. The Prior Art
It is often necessary to obtain tissue samples for examination from deep within luminal structures. These samples can only be retrieved by catheterization methods using endoscopic or fluoroscopic control, or by blind palpation. The biopsy devices used for these techniques remove 1 to 4 specimens that are retrieved by removing the biopsy instrument from the patient, and placing the specimen in a container of fixative solution labeled with the biopsy site and patient identification. The biopsies obtained in each pass are processed in a batch, since the minute pieces cannot be easily separated. Consequently, biopsies from different sites must be handled separately, thus requiring considerable effort and expense. The need to perform multiple biopsy passes because of the limited storage capacity of the biopsy instrument and the need to identify the sites of biopsy origin prolongs the procedure and may even cause it to fail, if the position of the biopsy instrument cannot be reacquired.
The batch of containers for each patient is then transported to the laboratory where the containers are serially opened and the specimens transferred to numbered cassettes that are recorded for later identification. The cassettes are then processed for examination. The processed specimens are then sliced, stained and mounted on labeled slides for microscopic examination. The specimens in each container must be processed separately to maintain identification. This is particularly important when the distribution and extent of a cancer is being mapped to determine the possibility of surgical removal and to prevent errors in reporting.
During this complex handling process, small specimens may be lost or damaged. At each stage of handling, the staff is exposed to possible infection from the biopsies particularly true when the unfixed specimen is removed from the sharp biopsy instrument before it is fixed. The staff is also exposed to solvent vapor from the fixative at each transfer step of processing. The solvents may be allergenic or carcinogenic. This tedious, labor intensive process is also expensive both in terms of time and laboratory space.
Although the prior art has made biopsy deep within the patient possible, the need for additional improvements remains. The present invention satisfies this need in a novel and unobvious way.